DIN Standards Committee Medicine
DIN EN 13624
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase2, step 1); German version EN 13624:2013
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Prüfung der fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1); Deutsche Fassung EN 13624:2013
This European Standard specifies a test method and the minimum requirements for fungicidal or levurocidal (yeasticidal) activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. Within the framework of revision, the requirements which have thus far been specified only for instrument disinfection have been expanded to general surfaces and hands. The annex on the precision of the test results has been rendered more precise based on the collaborative studies carried out. The standard has furthermore been harmonized with other standards of CEN/TC 216. The committee responsible for this standard is NA 063-04-07 AA "Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin" ("Chemical disinfectants and antiseptics in human medicine") at DIN.